Comparison · NCT00856206-sae
Rilonacept 160 mg vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Rilonacept 160 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00856206-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00856206-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0315 | 0.0223 | 0.0443 | wilson | |
| Risk in group 2 | 0.0394 | 0.0232 | 0.0662 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00792 | -0.0363 | 0.0128 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.799 | 0.423 | 1.51 | log | |
| Odds ratio, group 1 over group 2 | 0.792 | 0.41 | 1.53 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rilonacept 160 mg than on Placebo | 126 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rilonacept 160 mg | Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15. | 31 | 985 | EG001 |
| Group 2 | Placebo | Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. | 13 | 330 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
- NCT number
- NCT00856206
- Phases
- PHASE3
- Conditions
- Gout
- Interventions
- Rilonacept, Placebo
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2017-04-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00856206?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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